Staying current with the ever-changing regulatory landscape is challenging. New changes emerge almost every day, and a lack of harmonization across all the regions you work in only adds to the complexity. If you’re not referencing the most recent guidance documents, you may be introducing unnecessary compliance risks, including citations, fines, and failed submissions – ultimately wasting time, money and resources.
We’ve removed the hard work of finding, integrating and analyzing regulatory information so you can focus on the critical decisions needed to get your products to market faster. Access Cortellis Regulatory Intelligence™ to get comprehensive, global, and expertly-analyzed information that spans all regulatory functions across the R&D lifecycle – all in one central location. With Cortellis as part of your standard workflow, you can confidently comply with regulatory guidelines, increase submission approval rates, and successfully launch in markets worldwide.
Monitor regulatory changes using comparison tables that are continuously updated and linked to regulatory source documents, such as FDA483s, approval documents, inspection reports, and submission forms. And, download our mobile app to get the latest updates sent to your smartphone.
"Since I have Cortellis Regulatory Intelligence, I can find out the updates faster than waiting for the licensee notices."
Efficiently compare regulatory requirements across countries with detailed summaries of local regulatory practices and reference documents in English, translated by regulatory professionals who are also native language speakers.
"The global regulatory comparisons are very useful to compare specific issues between regions."
Prepare for inspections, monitor drug approval trends and maintain compliance with GXP and drug safety reporting requirements using searching inspection documents and proprietary regulatory intelligence reports – all manually curated by our editorial team.
"Cortellis Regulatory Intelligence allows us to have a cross-checking system… and to work in regulatory strategy in countries where commercial markets exist with no defined partners."
Conduct pre- and post-marketing surveillance, stay compliant, and understand approvals using comprehensive coverage of FDA AdComm meetings and workshops.
"Cortellis Regulatory Intelligence allows us to have a cross-checking system in place and to work on regulatory strategy in countries where commercial markets exist with no defined partners."
Clarivate experts bring together a unique combination of Cortellis content (and other available data sources) with experienced consultants and proprietary methodologies to drive life sciences innovation faster. Get independent objectivity, for better results. Our experts bring you unrivaled data science expertise, evidence-based consulting, and independent advice across the pharmaceutical R&D value chain.
Get the latest updates via customized alerts sent to your smartphone with our mobile app.
Prepare for inspections, understand trends in drug approvals, discern submission requirements and instructions, and much more.
Avoid the need to access multiple regulatory authority websites to understand which fit best with your strategy by quickly comparing regulations across countries.
Regulatory documents for drugs, biologics, medical devices, and IVDs
Countries and regions
Regulatory intelligence reports
Exclusive English translations
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Receive daily insights on the latest biopharma news and medical technology advances to better inform crucial R&D decisions at the earliest research stages.
Contact us to schedule a demo of Cortellis Regulatory Intelligence.